Job Posting

Senior Manager, External Manufacturing CMC

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About us

Ray Therapeutics is developing novel optogenetics gene therapies for patients with blinding diseases. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need. The company’s mission is to use optogenetics to restore vision, independent of genetic mutation for patients with inherited retinal diseases. Ray Therapeutics is based in the San Francisco Bay Area. For additional information, please visit our About Us page.

Position Summary:

Ray Therapeutics’ (RayTx) mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications. Ray Therapeutics is based in Berkeley, California.

We are currently seeking an exceptional leader as Senior Manager, External Manufacturing to join our team in the mission to restore vision to patients. The Senior Manager, External Manufacturing will work closely with and report to our VP, CMC in all aspects of outsourced early and late phase/commercial manufacturing operations for our AAV optogenetic therapeutic products.  The position requires hands-on GMP AAV manufacturing experience with the ability to be a team player both internally and with our external partners.   The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require travel to our contract development and manufacturing organizations in the United States.

Essential Duties and Responsibilities:

  • Contribute to CMC plans from research to pre-IND and later phase development including pivotal Phase 2/3 studies.
  • Serve as the primary point of contact with CDMO vendors.
  • Review and provide technical feedback on CDMO GMP documentation including, but not limited to, master production records, test procedures, deviations, CAPAs and completed records.
  • Assist with internal manufacturing tracking and trending systems which includes in-process and release testing results as well as manufacturing process parameters and raw materials.
  • Maintain inventory spreadsheets and COA/COTs for plasmids, cell banks and drug products at CDMO and product distribution center.
  • Track and manage CMC deliverables and to ensure strategies and plans are incorporated into full program development plans by collaborating with the project management team.
  • Contribute to risk mitigation strategies and effectively communicate them to the internal team.
  • Regularly update the leadership team on progress, data, risks, and forecasting of future CMC project needs.
  • Provide manufacturing insight on project plans for research, nonclinical, and clinical programs.
  • Support and assist the product distribution lifecycle from CDMO to depot to clinical sites.

Qualifications and Experience:

  • Must have a degree in relevant scientific or engineering discipline with 8+ years of industry experience with a proven track record of success
  • Hands-on experience in GMP AAV gene therapy manufacturing required
  • Late phase GMP AAV manufacturing experience preferred
  • Knowledge of AAV analytical methods and testing
  • Experience with managing external CDMOs
  • Excellent scientific knowledge and acumen

Working Conditions:

  • Prolonged periods of being at a stationary desk or on a work computer
  • Ability to occasionally adjust, handle, or move objects up to 20 pounds
  • Ability to assess the accuracy, neatness, and/or thoroughness of the work assigned
  • Travel up to 40% within the United States and will vary from time to time based on business requirements

Ray Therapeutics does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Ray Therapeutics offers a competitive total rewards package that includes a market competitive base salary, target bonus, and equity in addition to health care benefits.

Please submit please submit your resume and cover letter to: careers@raytherapeutics.com

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